Powered wearable hip exercise device to improve walking and balance in people with hip disease.
Study to Verify Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Hip Joint Diseases: Investigator Initiated, Single Center, Single Group Clinical Trial
We will test whether a powered wearable hip exercise device helps people with hip osteoarthritis or femoral head osteonecrosis walk farther, faster, and with better balance.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin-si, Gyeonggi-do, South Korea) |
| Trial ID | NCT07147530 on ClinicalTrials.gov |
What this trial studies
This is an investigator-initiated exploratory pilot with a single group of 30 participants to measure gait and balance with and without an electrically powered orthopedic exercise device. Participants undergo standardized gait and balance tests (10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go, Berg Balance Scale) under supervised conditions with rest periods between assessments. Device use, fitting, and all assessments are conducted under the prescription and guidance of rehabilitation specialists and trained staff. The study compares performance in non-wearing and wearing conditions to characterize safety and short-term functional effects.
Who should consider this trial
Good fit: Adults (aged 19+) with hip osteoarthritis (Kellgren-Lawrence Grade 1–4) or avascular necrosis of the femoral head (ARCO Stage 1–4) who can sit and stand briefly, have Functional Ambulatory Category scores of 1–3, and sufficient cognitive function are ideal candidates.
Not a fit: Patients with contraindications to lower-limb weight-bearing such as severe joint contractures, osteoporosis, untreated fractures, progressive unstable neurological disease, active infections or open wounds, or severe cognitive impairment are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could improve walking speed, endurance, and balance, helping patients maintain mobility and possibly delay more invasive treatments.
How similar studies have performed: Related studies of powered wearable orthoses and robotic assistive devices have shown gait improvements in stroke and other mobility disorders, but evidence specific to hip osteoarthritis or femoral head osteonecrosis is limited and preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals aged 19 or older 2. Individuals diagnosed with hip osteoarthritis of Kellgren-Lawrence (K-L) Grade 1-4 3. Individuals diagnosed with avascular necrosis of the femoral head at Association Research Circulation Osseous(ARCO) Stage 1-4 4. Individuals able to sit at the edge of a bed without assistance and stand for 10 seconds regardless of support 5. Individuals who are Functional Ambulatory Category (FAC) score of 1-3 6. Individuals who visited Yongin Severance Hospital, understood the study, and signed informed consent 7. Individuals who have adequate cognitive ability (Korean Mini-Mental State Examination score ≥ 20) Exclusion Criteria: 1. Individuals who have contraindications for lower limb weight-bearing such as severe joint contractures, osteoporosis, or untreated fractures 2. Individuals who have progressive or unstable brain diseases or neurological paralysis from stroke 3. Individuals who have active infections or open wounds hindering device use 4. Individuals who have significant leg length discrepancies 5. Individuals who have severe deformities or contractures in the lower extremities 6. Individuals who have history of poliomyelitis 7. Individuals inable to maintain seated or standing positions independently 8. Individuals who have severe spasticity (Modified Ashworth Scale grade ≥ 2) 9. Individuals who have bone metastases from cancer 10. Individuals who have severe internal diseases affecting device use (e.g., cardiovascular or respiratory diseases) 11. Individuals who have cognitive impairments preventing cooperation with device use 12. Individuals who have complaints of device-related side effects or potential rehabilitation discontinuation 13. Patients who are determined to be pregnant or potentially pregnant based on the medical interview 14. Individuals who have any other clinically significant findings deemed inappropriate by the investigator
Where this trial is running
Yongin-si, Gyeonggi-do, South Korea
- Yongin Severance Hospital — Yongin-si, Gyeonggi-do, South Korea, South Korea (Recruiting)
Study contacts
- Principal investigator: Na Young Kim, MD, PhD — Severance Hospital
- Study coordinator: Na Young Kim, MD, PhD
- Email: kny8452@yuhs.ac
- Phone: +82 010 9127 4482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.